{"id":3891154,"url":"https://alion.io/job/weil-group-inc-computer-system-validation-specialist-csv","title":"COMPUTER SYSTEM VALIDATION SPECIALIST (CSV)","company":{"id":4465740,"name":"Weil Group, Inc","domain":"weilgroup.com","url":"https://alion.io/company/weilgroup","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"CATS","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-06T21:18:34Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-08T03:09:39Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Job OverviewWe are seeking experienced Computer System Validation (CSV) Specialists to support the validation, implementation, maintenance, and lifecycle management of computerized systems within a regulated pharmaceutical manufacturing environment.\nThe ideal candidate will have hands-on experience executing computer system validation activities, developing and reviewing validation documentation, performing risk assessments, and ensuring compliance with applicable regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, and GMP standards.\nThis position will collaborate with Automation, Information Technology (IT), Engineering, Manufacturing, Quality Assurance, and system vendors to ensure computerized systems are appropriately validated, maintained in a controlled state, and capable of supporting reliable and compliant manufacturing operations.\nKey Responsibilities\nComputer System Validation & Lifecycle Management\nPlan, coordinate, and execute computer system validation activities throughout the system lifecycle, including implementation, upgrades, modifications, and periodic reviews.\nDevelop, review, and execute validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Validation Summary Reports.\nEnsure computerized systems meet intended-use requirements, established acceptance criteria, and applicable regulatory expectations.\nPerform risk-based validation assessments to determine appropriate testing strategies, documentation requirements, and validation scope.\nSupport the maintenance of computerized systems in a validated state throughout their operational lifecycle.\nAutomation & Manufacturing Systems\nSupport validation activities for computerized systems associated with pharmaceutical manufacturing, process automation, laboratory operations, and quality management.\nCollaborate with Automation and Engineering teams on systems such as PLCs, SCADA, HMI, DCS, MES, and other manufacturing control platforms, as applicable.\nReview system configurations, functional requirements, interfaces, data flows, and automated process controls to ensure compliance with approved specifications.\nSupport system implementation, upgrades, software changes, integrations, and troubleshooting activities from a validation perspective.\nCoordinate with system owners, vendors, and technical teams to evaluate system functionality and resolve validation-related issues.\nRegulatory Compliance & Data Integrity\nEnsure validation activities comply with applicable FDA regulations, including 21 CFR Part 11, GMP requirements, and relevant GAMP 5 guidance.\nEvaluate computerized systems for data integrity controls, including audit trails, electronic records, electronic signatures, user access, security, and data retention.\nApply ALCOA+ data integrity principles to computerized system documentation, testing, and operational controls.\nParticipate in system assessments to identify compliance gaps and recommend appropriate corrective or preventive actions.\nSupport internal audits, regulatory inspections, and quality assessments by providing validation documentation and technical justification.\nTesting, Deviations & Change Control\nDevelop and execute risk-based test scripts to verify system functionality, security, data integrity, and compliance with approved requirements.\nDocument test results, discrepancies, deviations, and supporting evidence in accordance with established procedures.\nInvestigate validation discrepancies, assess potential quality impacts, and coordinate corrective actions with appropriate stakeholders.\nEvaluate proposed system changes to determine validation impact, testing requirements, and documentation updates.\nSupport change control activities associated with software modifications, system upgrades, configuration changes, and infrastructure improvements.\nDocumentation & Cross-Functional Coordination\nMaintain complete, accurate, and traceable validation documentation in accordance with applicable procedures and document control requirements.\nCoordinate validation deliverables, testing schedules, and system readiness activities with project teams and system owners.\nParticipate in technical reviews, validation meetings, and project status discussions.\nSupport the preparation and review of Standard Operating Procedures (SOPs), system administration procedures, and related lifecycle documentation.\nProvide technical support and guidance to cross-functional teams regarding CSV requirements, validation practices, and compliance expectations.\nQualifications & Requirements\nMandatory Qualifications\nBachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.\nHands-on experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, medical device, or other FDA-regulated environments.\nExperience developing, reviewing, and executing validation protocols and associated lifecycle documentation.\nWorking knowledge of FDA 21 CFR Part 11, GMP regulations, GAMP 5, and computer system validation principles.\nExperience with risk assessments, requirements traceability, validation testing, deviations, and change control processes.\nUnderstanding of data integrity requirements, electronic records, electronic signatures, and computerized system controls.\nAbility to interpret technical specifications, system requirements, and validation documentation.\nStrong technical writing, analytical, problem-solving, and organizational skills.\nAbility to work effectively with multidisciplinary teams, including Automation, IT, Engineering, Manufacturing, and Quality.\nExcellent communication skills in English and Spanish.\nPreferred Qualifications\nPrevious experience validating manufacturing automation systems in pharmaceutical or biopharmaceutical facilities.\nExperience with PLC, SCADA, HMI, DCS, MES, or related industrial automation platforms.\nFamiliarity with computerized systems supporting sterile manufacturing, packaging, laboratory operations, or process control.\nExperience with risk-based validation approaches and computerized system lifecycle management under GAMP 5.\nKnowledge of computerized system infrastructure, system interfaces, network architecture, and data management practices.\nExperience supporting regulatory inspections, internal audits, and remediation of computerized system compliance gaps.\nFamiliarity with electronic validation management systems and computerized quality management platforms.\nExperience supporting commissioning, qualification, and integration activities for automated manufacturing equipment.\n*Weil Group is proud to be an Equal Employment Opportunity Employer.*","description_format":"text","description_chars":6778,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-11-06T21:18:34Z"}],"visa":[],"liveness":{"score":51,"band":"ok","label":"Likely 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